Cleared Traditional

K981255 - SIGMA DIAGNOSTICS ACCUCLOT CONTROL III

K981255 is the FDA 510(k) clearance for SIGMA DIAGNOSTICS ACCUCLOT CONTROL III by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K981255 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
23d
Days
Class 2
Risk

K981255 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS ACCUCLOT CONTROL III. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 29, 1998 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K981255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date April 29, 1998
Days to Decision 23 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K981255.
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · Bio-Rad · Apr 1999
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · Sigma Diagnostics, Inc. · Apr 1998
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co. · Jun 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · Bio-Rad · Feb 1997
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996